Genomics and Metagenomics of Asthma Severity

Asthma Clinical Trial

— GEMAS  

Official title:

Genomics and Metagenomics of Asthma Severity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501926
• Other study ID #: PI-29/17
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University of La Laguna
• Contact: Maria Pino-Yanes, Ph.D.
• Phone: +34 922 316 502
• Email: mdelpino[@]ull.edu.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Genomics and Metagenomics of Asthma Severity (GEMAS) study aims to assess the role of genomics, the microbiome, and the interaction between them in the development of asthma exacerbations in European patients with asthma.

Description:

Asthma is a chronic inflammatory disease of the airways characterized by reversible airflow obstruction and a bronchial hyperreactivity in response to a variety of stimuli. In most patients, the onset of asthma symptoms may be controlled. However, many of them may manifest asthma attacks or crises of breathing called exacerbations, which occur with breathing problems, wheezing, coughing or tightness of chest, and may threaten their life. Such exacerbations are caused by a combination of environmental and genetic factors. However, since studies so far have been limited, a reduced number of genes associated with the predisposition to these complications have been identified. In addition, some studies have used next-generation DNA sequencing techniques to characterize the microbiome (i.e., microbial community) of the airways, finding changes related to asthma. The main hypothesis of the Genomics and Metagenomics of Asthma Severity (GEMAS) study is that exacerbations of asthma are caused by a combination of the intrinsic genetic factors of the individual, changes in the respiratory microbiome and the interaction between both factors. The objectives of this project are: 1) to identify genetic variants that are associated with asthma exacerbations; 2) to examine the changes occurring in the microbial communities of the oral cavity and respiratory tract in individuals with exacerbations; 3) to analyze the association of the host genetic variants and the microbiome changes related to exacerbations.

A total of 300 Spanish subjects with asthma with and without a history of asthma exacerbations in the past 12 months will be recruited. Saliva, nasal and pharyngeal samples will be collected to study the oral cavity and the upper respiratory tract microbiome through next-generation sequencing technologies. Sequencing of the 16S ribosomal RNA (16S rRNA) gene will allow to characterize the bacterial diversity and abundance, as well as to infer the functionality of the microbiome in each sample. These parameters will be used to establish correlations between the microbiome and the presence of asthma exacerbations. Finally, the association between the genetic variation associated with exacerbations in genomic studies and the measurements of abundance, diversity and functions related to exacerbations will be jointly examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female aged older or equal than 8 years and younger or equal than 85 years

• Physician diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines

• Treated on GINA step 1-5

Exclusion Criteria:

• One or more grandparents of non-European origin

• Pregnancy

• Coexistence of other chronic pulmonary disorders including cystic fibrosis, chronic obstructive pulmonary disease (emphysema or chronic bronchitis), or congenital disorders of the lungs or airways

• Known family relatedness (first or second degree) with another participant already included in the study

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Locations

Country	Name	City	State
Spain	Hospital Doctor Jose Molina Orosa	Arrecife
Spain	Hospital General de La Palma	Breña Alta
Spain	Hospital Universitario de Canarias	San Cristobal de la Laguna
Spain	University of La Laguna	San Cristobal de la Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Donostia	San Sebastián
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife

Sponsors (9)

Lead Sponsor	Collaborator
Maria Pino-Yanes	Consorcio Centro de Investigación Biomédica en Red, M.P., Hospital Doctor Jose Molina Orosa, Hospital General de La Palma, Hospital Universitario de Canarias, Hospital Universitario Donostia, Spanish Ministry of Science, Innovation, and Universities, University Hospital of the Nuestra Señora de Candelaria, University of La Laguna

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe asthma exacerbations	Defined by one of the following events because of asthma during the past year, the past 6 months, and the past week: oral corticosteroids use, emergency room visit, and/or hospitalizations	1 year
Secondary	Asthma control	Asthma control questionnaire (ACQ) score	1 week
Secondary	Asthma severity	Category of severity defined by treatment step according to GINA 2020 at recruitment	1 year
Secondary	Lung function measurement: forced expiratory volume in the first second (FEV1)	Baseline and post-bronchodilator measurements of the forced expiratory volume in the first second (FEV1) measured in liters	3 months
Secondary	Lung function measurement: forced vital capacity (FVC)	Baseline and post-bronchodilator measurements of the forced vital capacity (FVC) measured in liters	3 months
Secondary	Lung function measurement: FEV1/FVC ratio	The ratio of FEV1/FVC measurements	3 months
Secondary	Atopy testing	Atopy status evaluated by skin prick tests and/or specific immunoglobulin E (IgE) levels assessing the most common aeroallergens of each recruiting center	1 year